[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR491.9]

[Page 965-966]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                  HEALTH AND HUMAN SERVICES (CONTINUED)
 
PART 491_CERTIFICATION OF CERTAIN HEALTH FACILITIES--Table of Contents
 
Subpart A_Rural Health Clinics: Conditions for Certification; and FQHCs 
                         Conditions for Coverage
 
Sec. 491.9  Provision of services.

    (a) Basic requirements. (1) All services offered by the clinic or 
center are furnished in accordance with applicable Federal, State, and 
local laws; and
    (2) The clinic or center is primarily engaged in providing 
outpatient health services and meets all other conditions of this 
subpart.
    (3) The laboratory requirements in paragraph (c)(2) of this section 
apply to RHCs, but do not apply to FQHCs.
    (b) Patient care policies. (1) The clinic's or center's health care 
services are furnished in accordance with appropriate written policies 
which are consistent with applicable State law.
    (2) The policies are developed with the advice of a group of 
professional personnel that includes one or more physicians and one or 
more physician assistants or nurse practitioners. At

[[Page 966]]

least one member is not a member of the clinic or center staff.
    (3) The policies include:
    (i) A description of the services the clinic or center furnishes 
directly and those furnished through agreement or arrangement.
    (ii) Guidelines for the medical management of health problems which 
include the conditions requiring medical consultation and/or patient 
referral, the maintenance of health care records, and procedures for the 
periodic review and evaluation of the services furnished by the clinic 
or center.
    (iii) Rules for the storage, handling, and administration of drugs 
and biologicals.
    (4) These policies are reviewed at least annually by the group of 
professional personnel required under paragraph (b)(2) of this section 
and reviewed as necessary by the clinic or center.
    (c) Direct services--(1) General. The clinic or center staff 
furnishes those diagnostic and therapeutic services and supplies that 
are commonly furnished in a physician's office or at the entry point 
into the health care delivery system. These include medical history, 
physical examination, assessment of health status, and treatment for a 
variety of medical conditions.
    (2) Laboratory. These requirements apply to RHCs but not to FQHCs. 
The RHC provides laboratory services in accordance with part 493 of this 
chapter, which implements the provisions of section 353 of the Public 
Health Service Act. The RHC provides basic laboratory services essential 
to the immediate diagnosis and treatment of the patient, including:
    (i) Chemical examinations of urine by stick or tablet method or both 
(including urine ketones);
    (ii) Hemoglobin or hematocrit;
    (iii) Blood glucose;
    (iv) Examination of stool specimens for occult blood;
    (v) Pregnancy tests; and
    (vi) Primary culturing for transmittal to a certified laboratory.
    (3) Emergency. The clinic or center provides medical emergency 
procedures as a first response to common life-threatening injuries and 
acute illness and has available the drugs and biologicals commonly used 
in life saving procedures, such as analgesics, anesthetics (local), 
antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids.
    (d) Services provided through agreements or arrangements. (1) The 
clinic or center has agreements or arrangements with one or more 
providers or suppliers participating under Medicare or Medicaid to 
furnish other services to its patients, including:
    (i) Inpatient hospital care;
    (ii) Physician(s) services (whether furnished in the hospital, the 
office, the patient's home, a skilled nursing facility, or elsewhere); 
and
    (iii) Additional and specialized diagnostic and laboratory services 
that are not available at the clinic or center.
    (2) If the agreements are not in writing, there is evidence that 
patients referred by the clinic or center are being accepted and 
treated.

[57 FR 24983, June 12, 1992, as amended at 58 FR 63536, Dec. 2, 1993]